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Trial Title:
Effect of Mirabegron on Promoting Brown Adipose Tissue Activation
NCT ID:
NCT05779514
Condition:
Tumour
Conditions: Official terms:
Mirabegron
Conditions: Keywords:
brown adipose tissue
Mirabegron
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Mirabegron
Description:
Health Volunteers ：Mirabegron p.o. 28 days 100mg qd./ Tumor patients ：Mirabegron p.o. 28
days 100 mg qd or 200 mg qd.
Arm group label:
The growth of brown adipose tissue
Summary:
In previous preclinical studies, our group found that Mirabegron, a clinical drug, could
activate brown adipose tissue and inhibit tumor growth in tumour-bearing
mice.Investigators look forward to further evaluating the effect of Mirabegron-mediated
brown adipose tissue activation, so as to provide new drug applications for clinical
cancer prevention and treatment
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Health Volunteers
1. Sign the informed consent before the study, and fully understand the content,
process and possible adverse events.
2. Both men and women, aged 18-75 years (including the boundary value) .
3. Body mass index (BMI) is 19.0-26.0 kg/m2 (including the boundary value).
- Tumor patients
1. Sign the informed consent before the study, and fully understand the content,
process and possible adverse events.
2. Tumor bearing and not in the period of chemotherapy and targeted drug
intervention).
3. Both men and women, aged 18-75 years (including the boundary value) .
4. Body mass index (BMI) is 19.0-26.0 kg/m2 (including the boundary value).
5. Proper bone marrow and organ function, as defined below:HB≥80h/L;
ANC≥1.5*109/L; PLT≥50*109/L; ALT≤3 upper limit of normal ( ULN ); AST≤3 ULN ;
TBIL≤1.5 ULN.
6. The expected survival is 3 months or more.
Exclusion Criteria:
- Health Volunteers and Tumor patients
1. A history of tuberculosis infection.
2. Patients with contraindications to Mirabegron: allergic to Mirabegron or any of
its excipients; Patients with poorly controlled severe hypertension(SBP≧180mmHg
or/and DBP≧110mmHg).
3. Women who are pregnant or breastfeeding.
4. The subject may not be able to complete the study for other reasons or may not
be able to participate in the study for other reasons judged by the
investigator.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Zhejiang Provincial People's Hospital
Address:
City:
Hangzhou
Zip:
030000
Country:
China
Status:
Recruiting
Contact:
Last name:
Rui Hao
Phone:
15957145619
Email:
hao61977@163.com
Contact backup:
Last name:
Jiajie Xu
Phone:
13600517252
Email:
zjsrmyygcp@163.com
Start date:
August 18, 2022
Completion date:
December 31, 2023
Lead sponsor:
Agency:
Zhejiang Provincial People's Hospital
Agency class:
Other
Source:
Zhejiang Provincial People's Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05779514
